[April 26, 2017] |
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Teva Announces Launch of Generic Vytorin® in the United States
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced the launch of generic Vytorin®1 (ezetimibe and
simvastatin) tablets in the U.S.
Ezetimibe and simvastatin tablets are a prescription medicine that
contains two (2) cholesterol lowering medicines, ezetimibe and
simvastatin, which are used along with diet to:
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Lower the level of "bad" cholesterol (low density lipoprotein
cholesterol or LDL)
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Increase the level of "good" cholesterol (high density lipoprotein
cholesterol or HDL)
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Lower the level of fat in blood (triglycerides)
Ezetimibe and simvastatin tablets further enhance Teva's statin
portfolio. With nearly 600 generic medicines available, Teva has the
largest portfolio of FDA-approved generic products on the market and
holds the leading position in first-to-file opportunities, with over 100
pending first-to-files in the U.S. Currently, one in six generic
prescriptions dispensed in the U.S. is filled with a Teva product.
Vytorin® had annual sales of approximately $678 million in
the U.S. according to IMS data as of February 2017.
About Ezetimibe and Simvastatin Tablets Therapy with
lipid-altering agents should be only one component of multiple risk
factor intervention in individuals at significantly increased risk for
atherosclerotic vascular disease due to hypercholesterolemia. Drug
therapy is indicated as an adjunct to diet when the response to a diet
restricted in saturated fat and cholesterol and other nonpharmacologic
measures alone has been inadequate.
Ezetimibe and simvastatin tablets are indicated for the reduction of
elevated total cholesterol (total-C), low-density lipoprotein
cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and
non-high-density lipoprotein cholesterol (non-HDL-C), and to increase
high-density lipoprotein cholesterol (HDL-C) in patients with primary
(heterozygous familial and non-familial) hyperlipidemia or mixed
hyperlipidemia.
Ezetimibe and simvastatin tablets are indicated for the reduction of
elevated total-C and LDL-C in patients with homozygous familial
hypercholesterolemia, as an adjunct to other lipid-lowering treatments
(e.g., LDL apheresis) or if such treatments are unavailable.
Limitations of Use: No incremental benefit of ezetimibe and simvastatin
tablets on cardiovascular morbidity and mortality over and above that
demonstrated for simvastatin has been established. Ezetimibe and
simvastatin tablets have not been studied in Fredrickson type I, III,
IV, and V dyslipidemias.
Important Safety Information Ezetimibe
and simvastatin tablets are contraindicated in the following conditions:
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Concomitant administration of strong CYP3A4 inhibitors.
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Concomitant administration of gemfibrozil, cyclosporine, or danazol.
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Hypersensitivity to any component of this medication.
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Active liver disease or unexplained persistent elevations in hepatic
transaminase levels.
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Women who are pregnant or may become pregnant. Ezetimibe and
simvastatin should be administered to women of childbearing age only
when such patients are highly unlikely to conceive.
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Nursing mothers.
Simvastatin occasionally causes myopathy manifested as muscle pain,
tenderness or weakness with creatine kinase above ten times the upper
limit of normal (ULN). Myopathy sometimes takes the form of
rhabdomyolysis with or without acute renal failure secondary to
myoglobinuria, and rare fatalities have occurred. The risk of myopathy
is increased by high levels ofstatin activity in plasma. Predisposing
factors for myopathy include advanced age (greater than or equal to 65
years), female gender, uncontrolled hypothyroidism, and renal
impairment. The risk of myopathy, including rhabdomyolysis, is dose
related.
Persistent elevations in hepatic transaminase levels can occur. Active
liver diseases or unexplained persistent transaminase elevations are
contraindications to the use of ezetimibe and simvastatin. Increases in
HbA1c and fasting serum glucose levels have been reported with HMG-CoA
reductase inhibitors, including simvastatin. Common (incidence greater
than or equal to 2% and greater than placebo) adverse reactions in
clinical trials: headache, increased ALT, myalgia, upper respiratory
tract infection, and diarrhea.
For more information, please see accompanying Full
Prescribing Information.
About Teva Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that delivers
high-quality, patient-centric healthcare solutions used by approximately
200 million patients in 100 markets every day. Headquartered in Israel,
Teva is the world's largest generic medicines producer, leveraging its
portfolio of more than 1,800 molecules to produce a wide range of
generic products in nearly every therapeutic area. In specialty
medicines, Teva has the world-leading innovative treatment for multiple
sclerosis as well as late-stage development programs for other disorders
of the central nervous system, including movement disorders, migraine,
pain and neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements This
press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 regarding the
launch and potential benefits of Teva's generic version of Vytorin®,
which are based on management's current beliefs and expectations and are
subject to substantial risks and uncertainties, both known and unknown,
that could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
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commercial success of Teva's generic version of Vytorin®;
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our generics medicines business, including: that we are
substantially more dependent on this business, with its significant
attendant risks, following our acquisition of Allergan plc's worldwide
generic pharmaceuticals business ("Actavis Generics"); our ability to
realize the anticipated benefits of the acquisition (and any delay in
realizing those benefits) or difficulties in integrating Actavis
Generics; the increase in the number of competitors targeting generic
opportunities and seeking U.S. market exclusivity for generic versions
of significant products; price erosion relating to our generic
products, both from competing products and as a result of increased
governmental pricing pressures; and our ability to take advantage of
high-value biosimilar opportunities;
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our business and operations in general, including: our ability to
develop and commercialize additional pharmaceutical products;
manufacturing or quality control problems, which may damage our
reputation for quality production and require costly remediation;
interruptions in our supply chain; disruptions of our or third party
information technology systems or breaches of our data security; the
failure to recruit or retain key personnel, including those who joined
us as part of the Actavis Generics acquisition; the restructuring of
our manufacturing network, including potential related labor unrest;
the impact of continuing consolidation of our distributors and
customers; and variations in patent laws that may adversely affect our
ability to manufacture our products;
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compliance, regulatory and litigation matters, including: costs and
delays resulting from the extensive governmental regulation to which
we are subject; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; governmental
investigations into sales and marketing practices; potential liability
for sales of generic products prior to a final resolution of
outstanding patent litigation; product liability claims; increased
government scrutiny of our patent settlement agreements; failure to
comply with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks.
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 ("Annual Report"), including in the section
captioned "Risk Factors," and in our other filings with the U.S.
Securities and Exchange Commission which are available at www.sec.gov
and www.tevapharm.com.
Forward-looking statements speak only as of the date on which they are
made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise. You
are cautioned not to put undue reliance on these forward looking
statements. .
1 Vytorin® is a registered trademark of Merck &
Co., Inc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170426006674/en/
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